Panchani Sunil K, Divecha Hiren M, Lafferty Rebecca, Pavlou George, Oakley Jez, Shaw Debbie, Chitre Amol, Wynn Jones Henry, Raut Videsh, Smith Robert, Gambhir Anil, Board Tim
Wrightington Hospital, Wigan, United Kingdom.
JB JS Open Access. 2021 Jul 28;6(3). doi: 10.2106/JBJS.OA.21.00016. eCollection 2021 Jul-Sep.
Total knee replacement (TKR) designs continue to evolve with the aim of improving patient outcomes; however, there remains a significant patient dissatisfaction rate. We report the early functional outcomes of an evolutionary knee design in the context of a single-blinded, noninferiority, randomized controlled trial.
Patients were randomized to receive either the P.F.C. SIGMA or ATTUNE knee implant systems (DePuy Synthes). All implants were fixed-bearing, cruciate-retaining, and cemented constructs. Patients were assessed at baseline and 6 weeks, 3 months, and 1 year postoperatively using clinical and functional outcome measures, including range of motion, Oxford Knee Score (OKS), Oxford Knee Score-Activity and Participation Questionnaire (OKS-APQ), Patient Knee Implant Performance (PKIP) score, 5-Level EuroQol 5 Dimensions (EQ-5D-5L), and Short Form-36 outcome measures.
There were 150 patients who underwent a surgical procedure (76 with the ATTUNE implant and 74 with the P.F.C. SIGMA implant), with 147 patients remaining at the final review. No differences were observed in any of the outcome measures between the groups at any time point. Tourniquet time was significantly shorter in the P.F.C. SIGMA arm (p = 0.001); however, this had no clinical impact on the OKS (analysis of covariance [ANCOVA] test) at the final review (p = 0.825). There was no difference in the numbers of patients achieving the minimal clinically important difference for the OKS between the groups (p = 0.817).
This trial did not show inferiority of the ATTUNE implant when compared with the P.F.C. SIGMA implant. The authors believe that implant innovation should continue and that modern implants should be introduced into the market following randomized controlled trials. Further work should assess the effect of non-implant-related factors on patient outcomes.
Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.
全膝关节置换术（TKR）的设计不断发展，旨在改善患者预后；然而，患者的不满意率仍然很高。我们在一项单盲、非劣效性、随机对照试验的背景下报告了一种进化型膝关节设计的早期功能结果。
患者被随机分配接受P.F.C. SIGMA或ATTUNE膝关节植入系统（DePuy Synthes）。所有植入物均为固定平台、保留交叉韧带且使用骨水泥的结构。在基线以及术后6周、3个月和1年时，使用临床和功能结局指标对患者进行评估，这些指标包括活动范围、牛津膝关节评分（OKS）、牛津膝关节评分 - 活动与参与问卷（OKS - APQ）、患者膝关节植入物性能（PKIP）评分、5级欧洲五维健康量表（EQ - 5D - 5L）以及简短健康调查36项量表（Short Form - 36）结局指标。
有150例患者接受了手术（76例使用ATTUNE植入物，74例使用P.F.C. SIGMA植入物），147例患者在最终评估时仍参与研究。在任何时间点，两组之间的任何结局指标均未观察到差异。P.F.C. SIGMA组的止血带使用时间明显更短（p = 0.001）；然而，在最终评估时，这对OKS没有临床影响（协方差分析[ANCOVA]检验，p = 0.825）。两组之间达到OKS最小临床重要差异的患者数量没有差异（p = 0.817）。
与P.F.C. SIGMA植入物相比，本试验未显示ATTUNE植入物具有劣势。作者认为植入物创新应继续进行，并且现代植入物应在随机对照试验后推向市场。进一步的工作应评估非植入物相关因素对患者结局的影响。
治疗性I级。有关证据水平的完整描述，请参阅作者指南。
